Friday, January 29, 2010

Tennessee state representative Mike Turner introduced legislation earlier this year which would have denied health insurance coverage to all new state employees who smoke or use other tobacco products. Turner argued that the proposal was intended to control rising health care costs for the state.

Just the fact that a bill like this could even be considered is scary. Given the health risks associated with tobacco use, smokers are a group who probably need health care coverage the most. To deny coverage to this group makes no sense and would cause massive harm to the public's health.

The same reasoning that supports this legislation would also support denying health insurance to people who are overweight, eat poorly, do not exercise, or practice unsafe sex.

Perhaps we should only insure people who have the most healthy lifestyles. That would be a sure way to drive health care costs down. Of course, it would also result in the overwhelming majority of the population being uninsured. We'd end up paying for their health care anyway, but at least it would make them feel alienated and socially outcast.

It looks like the health care debate is going the wrong way in Tennessee. I thought we were trying to maximize the number of people with health care coverage, not minimize it.

Thursday, January 28, 2010

According to the authors of a published "Views and Reviews" article in this week's issue of the British Medical Journal, active smoking is probably no worse than using electronic cigarettes.

The article, entitled "Electronic Cigarettes: Miracle or Menace?," reviews the current state of scientific knowledge about the safety of electronic cigarettes compared to traditional cigarettes. It concludes that: "The scarce evidence indicates the existence of various toxic and carcinogenic compounds, albeit in possibly much smaller concentrations than in traditional cigarettes."

The paper then concludes: "More rigorous chemical analyses are needed, followed by extensive research involving animal studies and, finally, clinical trials in humans. Until these crucial implementation stages are completed, physicians and other healthcare professionals must inform consumers of the probable fallaciousness of the claims of manufacturers of e-cigarettes."

The Rest of the Story

The main claim being referred to in the commentary is the claim that electronic cigarettes represent a safer alternative to traditional cigarettes. If such a claim is fallacious, it would mean that electronic cigarettes are no less hazardous than regular cigarettes. In other words, it would mean that regular cigarettes are no more hazardous than electronic ones. Thus, what the authors of this article are actually stating is that regular cigarettes are probably no more harmful than electronic ones.

Such an assertion is beyond belief. It is completely inconsistent with everything we know about toxicology and pathology and there is no scientific basis for such a statement. It conflicts directly with even the stated conclusion of the article itself, which acknowledges that the levels of hazardous components in electronic cigarettes are likely much lower than in traditional cigarettes. By what law of chemistry or medicine do the authors assert that the presence of much higher levels of many more toxins and carcinogens fail to make cigarettes more hazardous than these electronic devices?

I believe that this conclusion is not only unsupported by scientific evidence or common sense, but it is also irresponsible. Because it is telling physicians to inform their patients of something which is almost certainly untrue: that smoking cigarettes is no more hazardous than inhaling vaporized nicotine from a tobacco-free device that delivers primarily nicotine and propylene glycol and which for at least some major brands has been found not to contain any detectable levels of tested carcinogens.

The danger of this statement is that it could encourage ex-smokers who have successful quit by using electronic cigarettes to return to smoking. That would be medical malpractice in my view.

The most troubling aspect of this commentary, to me, is the twisted (and inaccurate) logic used in presenting the final argument. After presenting a fair and balanced summary of the state of scientific knowledge, the authors make a sudden and it seems almost mandatory assertion that electronic cigarettes are probably no safer than real ones. The logic is flawed, however, because they confuse the failure to prove a hypothesis with the likelihood of that hypothesis being true.

In other words, the authors argue that because the hypothesis that electronic cigarettes are safer than real ones has not been definitively proven, it is probably not true. But the likelihood of the hypothesis being true has nothing to do with whether it has been studied or not. These are completely independent!

Not according to the logic of these authors. Based on their logic, because it has not been demonstrated that electronic cigarettes are safer than real ones, it is most likely not true. But again, the fact that this hypothesis has not been definitively studied does not affect the likelihood of its being true.

By this logic, anything that has not yet been studied is most likely untrue. Since we have not yet studied whether smoking six packs of cigarettes a day is more harmful than smoking one pack a day, it is most likely untrue. Since we have not studied whether an electronic cigarette which delivers pure water is safer than a Marlboro, it is most likely not true.

This is obviously absurd and fallacious reasoning.

The presence of this twisted and fallacious reasoning in this scientific paper is disturbing to me because it suggests that the bias against smokers has become so strong that it is tainting even the published scientific literature, and even in as prestigious a journal as the BMJ.

Sure, it is true that there are no clinical trials which have demonstrated that electronic cigarettes are safer than regular ones. Such studies are urgently needed. But the absence of those studies does not provide evidence that electronic cigarettes are as hazardous as smoking Marlboro 100's.

We cannot let ideology wipe out our ability to make sound scientific judgments and use rational analysis in evaluating public policy. In this case, the blinding ideology is apparently the view that the very act of doing something which looks like smoking is bad.

Wednesday, January 27, 2010

Do Anti-Smoking Groups Still Want Ex-Smokers to Return to the Real Thing?

Laboratory testing of inLife electronic cigarettes has confirmed that there are no detectable levels of either tobacco-specific nitrosamines (TSNA's) or diethylene glycol (DEG) (see: full report #1; full report #2). The testing was conducted by Alliance Technologies. No DEG was detected either in the electronic cigarette cartridge (liquid) or vapors. For the TSNA testing, only the liquid was tested (but there won't be any TSNA's in the vapor if they are not present in the liquid).

Previously, NJOY announced that testing of its electronic cigarette products revealed no carcinogenic TSNA's in the vapor produced by the device. FDA testing had detected trace levels of TSNA's in the liquid. But NJOY's testing of the vapor revealed no detectable levels of three carcinogenic TSNA's. Trace levels of a fourth TSNA were detected, but that component is not believed to be toxic, according to NJOY. In contrast, detectable levels of the highly carcinogenic TSNAs NNN and NNK were found in nicotine replacement products.

The results of laboratory testing of inLife electronic cigarettes are available on a new web site which presents detailed information about electronic cigarettes and helps to debunk many of the myths about these products which have been disseminated by anti-smoking groups.

The Rest of the Story

Despite the initial scare instilled into the American public by the FDA, subsequent testing has revealed no evidence that there is any appreciable exposure to carcinogens from inhaling the electronic cigarette vapor and the DEG scare seems to be limited to a single e-cigarette brand. The inLife electronic cigarette product, we now know, is free of detectable levels of either TSNA's or DEG. Thus, claims about these two major hazards of electronic cigarettes, made by anti-smoking groups calling for their removal from the market, have now been debunked.

So far, anti-smoking groups which want electronic cigarettes removed from the market have pointed to just two potential hazards from these products: (1) carcinogenic exposure from tobacco-specific nitrosamines; and (2) exposure to diethylene glycol. This testing of inLife and other electronic cigarettes is significant because it demonstrates that for at least some of the e-cigarette products on the market, neither of these two alleged health hazards is a problem.

Which means - there are currently no alleged health hazards of many of the brands of electronic cigarettes on the market. Yet, anti-smoking groups still want these products to be removed from the market, forcing thousands of ex-smokers to return to regular cigarette smoking.

That is a policy which would, with near certainty, lead to increased disease and death.

Yet that's the policy being supported by a number of major anti-smoking groups.

Clearly, protecting the public's health is not the sole concern or motivating factor for these anti-smoking groups.

Monday, January 25, 2010

Proving untrue the Campaign for Tobacco-Free Kids' assertion that the FDA tobacco law will allow us, for the first time, to find out the ingredients in cigarettes, R.J. Reynolds Tobacco Company has published online the complete list of ingredients for each of its cigarette brands, along with the maximum amount of each ingredient.

As R.J. Reynolds points out, most of the additives are either commonly used in foods and beverages, explicitly approved for use in food by the FDA, or generally recognized as safe for use in foods.

Here is the complete list of ingredients, other than tobacco, used by R.J. Reynolds in the manufacture of its cigarettes:

Acetanisole

Acetic Acid

Acetoin

Acetophenone

2-Acetylpyrazine

3-Acetylpyridine

Ammonium Alginate

Ammonium Hydroxide

Amyl Butyrate

Amyl Octanoate

Amyris Oil

trans-Anethole

Anisic Aldehyde

Ascorbic Acid

Balsams, Peru

Beeswax Resinoid

Benzaldehyde

Benzaldehyde

Benzoic Acid

Benzyl Alcohol

Benzyl Benzoate

Benzyl Cinnamate

Bornyl Acetate

Brown Sugar

Butanoic Acid, 3-Methyl-, 4-Methylphenyl Ester

Butanol, 3-Methyl-, Benzoate, 1-

Butyl Alcohol

n-Butyl Isovalerate

Butyric Acid

Caramel Color

Caramel (Plain)

Carbon

Carbon Dioxide

Cardamon Oil

Carob Bean Extract

Carrot Seed Oil

l-Carvone

Caryophyllene

Caryophyllene Oxide

Celery Seed Oil

Cellulose Fiber

Chicory Extract

Chocolate Liquor

Cinnamaldehyde

Cinnamon Bark Oil

Citral

Citric Acid

Citronella Oil

Clary Sage Oil

Cocoa (Extract, Powder, Extractive, Tincture, Distillate, Absolute)

Coffee Beans, Ground

Coriander Oil

Corn Syrup

Damascenone

Davana Oil

delta-Decalactone

gamma-Decalactone

Decanoic Acid

Dextrose

Diammonium Phosphate

Diethyl Malonate

2,6-Dimethoxyphenol

Dimethyl Benzyl Carbinol Butyrate

Dimethyl Sulfide

3,4-Dimethyl-1,2-Cyclopentadione

4,5-Dimethyl-3-Hydroxy-2,5-Dihydrofuran-2-one

2,5-Dimethylpyrazine

Dodecahydro-3A,6,6,9A-Tetramethylnaptho-(2,1-b)-Furan

delta-Dodecalactone

gamma-Dodecalactone

Ethyl Acetate

Ethyl Benzoate

Ethyl Butyrate

Ethyl Caproate

Ethyl Cyclotene

Ethyl Decanoate

Ethyl Heptanoate

Ethyl Levulinate

Ethyl Maltol

Ethyl Methyl Phenyl Glycidate

Ethyl Myristate

Ethyl Nonanoate

Ethyl Octanoate

Ethyl Pentanoate

Ethyl Phenylacetate

3-Ethyl Pyridine

Ethyl Vanillin

4-Ethyl-2-Methoxy-Phenol

Ethyl-2-Methylbutyrate

2-Ethyl-3,5(or 6)-Dimethylpyrazine

5-Ethyl-3-Hydroxy-4-Methyl-2(5H)-Furanone

2-Ethyl-3-Methylpyrazine

Eucalyptol

Fenugreek Absolute/Extract

Fenugreek Seed

Fig Juice Concentrate

Furaneol

Geraniol

Geranium Bourbon Oil

Geranyl Acetone

Glycerides, mixed decanoyl and octanoyl

Glycerol

Graphite

Guaiacol

Guar Gum

Helichrysum Absolute

gamma-Heptalactone

Heptanoic Acid

omega-6-Hexadecenlactone

gamma-Hexalactone

Hexanal

Hexanoic Acid

3-Hexanoic Acid

1-Hexanol

2-Hexen-1-ol

cis-3-Hexen-1-yl Acetate

cis-3-Hexenol

Hexyl Acetate

Hexyl Phenylacetate

High Fructose Corn Syrup

Honey

Hydroxyphenyl)-Butan-2-one, 4-(para-

Invert Sugar

alpha-Ionone

beta-Ionone

alpha-Irone

Isoamyl Acetate

Isoamyl Butyrate

Isoamyl Isovalerate

Isobutyl Phenylacetate

2-Isobutyl-3-Methoxy Pyrazine

Isobutyraldehyde

Isovaleraldehyde

Isovaleric Acid

Jasmine Absolute

Labdanum Absolute

Lactic Acid

Lauric Acid

Lemon Oil

Lemongrass Oil

Levulinic Acid

Licorice

Licorice Extract Powder

Lime Oil

Linalool

Linalool Oxide

Linalyl Acetate

Linoleic Acid

Lovage Root

Maltol

Mate Extract

para-Mentha-8-Thiol-3-one

Menthol

l-Menthone

2-Methoxy-3-Methyl-Pyrazine

2-Methoxy-4-Methylphenol

Methyl Dihydrojasmonate

Methyl Linoleate/Methyl Linolenate

2-Methyl Pentanoic Acid

Methyl Salicylate

trans-2-Methyl-2-Butenoic Acid

Methyl-2-Furoate

Methyl-2-Pyrrolyl Ketone

2-Methyl-3((5 or 6)Furfurylthio)pyrazine

6-Methyl-3,5-Heptadien-2-one

6-Methyl-5-Hepten-2-one

4-Methylacetophenone

2-Methylbutyric Acid

Methylcyclopentenolone

2-Methylpyrazine

5-Methylquinoxaline

3-Methylvaleric Acid

Myristic Acid

Myrrh Absolute

Myrrh Extract

Myrrh Oil

Nerol

Neroli Bigarade Oil

Nerolidol

2,6-Nonadien-1-ol

gamma-Nonalactone

Nonanoic Acid

gamma-Octalactone

Octanal

Octanoic Acid

1-Octen-3-ol

2-Octenal, (E)-

Olibanum Oil

Orange Oil

Orange Oil Terpenes

Orange Sweet Terpeneless Oil

Orris Root Extract

Palmitic Acid

Patchouli Oil

Pogostemon cablin Benth

Patchouly Absolute

omega-Pentadecalactone

2,3-Pentanedione

Pepper Oil, Black

Peppermint Oil, Terpeneless

Peru Balsam Oil

Phenyl-2-Propenoic Acid Ethyl Ester, 3-

Phenyl-2-Propenoic Acid, 3-

Phenylacetaldehyde

Phenyl Acetic Acid

Phenethyl Acetate

Phenethyl Alcohol

alpha-Pinene

Piperonal

Potassium Carbonate

Potassium Sorbate

Propyl Acetate

Propylene Glycol

Prune Juice Concentrate

Rose Oil (Turkish)

Rosemary Oil

Salicylic Aldehyde

Sandalwood Oil, Yellow

Sodium Carbonate

Sodium Citrate

Scotch Spearmint Oil

Sucrose

alpha-Terpineol

alpha-Terpinyl Acetate

5,6,7,8-Tetrahydroquinoxaline

2,3,5,6-Tetramethylpyrazine

Thymol

para-Tolualdehyde

Triethyl Citrate

3,5,5-Trimethyl-1,2-Cyclohexanedione

2,6,6-Trimethyl-2-Cyclohexene-1, 4-Dione

4-(2,6,6-Trimethylcyclohex-1-enyl) but-2-en-4-one

2,3,5-Trimethylpyrazine

delta-Undecalactone

gamma-Undecalactone

2-Undecanone

Urea

Valerian Root Oil

gamma-Valerolactone

Vanilla Oleoresin

Vanillin

Veratraldehyde

Vetiver Oil

Violet Leaves Absolute

Water

Wheat Absolute

R.J. Reynolds also provides the specific combination of ingredients present in each brand of its cigarettes. For example, the ingredients in Camel Filters Hard Pack are:

tobacco

water;

glycerol;

brown sugar;

propylene glycol;

high fructose corn syrup;

sucrose;

cellulose fiber;

cocoa;

licorice;

diammonium phosphate;

ammonium hydroxide; and

natural and artificial flavors.

The Rest of the Story

The stupidity of the FDA tobacco law, crafted by the Campaign for Tobacco-Free Kids and supported by the major, national anti-smoking groups, is that in response to this list of ingredients, the FDA has the authority to eliminate every single one of them ...

... except for the tobacco.

This may come as a surprise to the anti-smoking groups, but the one ingredient in the cigarettes which makes them the most hazardous consumer product on the market is ...

... the tobacco.

I feel like organizing a "It's the Tobacco, Stupid" march on Washington, D.C., and show up at the doorstep of the Campaign for Tobacco-Free Kids to inform them of the breaking news that the tobacco is the ingredient which makes cigarettes deadly, and they can remove all the other ingredients if they wish, but cigarettes will still be deadly and kill hundreds of thousands of people each year.

Moreover, there is not a shred of evidence that Camel Filter Hard Packs will be any less hazardous if the FDA bans the use of glycerol, brown sugar, propylene glycol, high fructose corn syrup, sucrose, cellulose fiber, cocoa, licorice, diammonium phosphate, ammonium hydroxide, and natural and artificial flavors.

If anything, banning these additives would be counterproductive because such an action would give the public a false sense of security about the improved safety of cigarettes and would divert attention from the real problem: the tobacco. In addition, it would essentially result in the government fraudulently deceiving consumers into believing that cigarettes have been made safer by virtue of the removal of the non-tobacco ingredients.

Remember - the removal of non-tobacco ingredients (i.e., additives) is already in place for one brand of cigarettes. Winston cigarettes contain only tobacco and water (look them up on the website if you don't believe me).

Does the Campaign for Tobacco-Free Kids truly believe that Winston cigarettes are safer than other brands? Do the national anti-smoking groups believe that by removing all additives, R.J. Reynolds has taken a step in the right direction? Do these anti-smoking groups truly believe that if all cigarette brands were required to take the step that Winston has taken, and remove all the additives, that the world would be a better place by virtue of the improved safety of cigarettes?

In fact, the anti-smoking groups don't believe this, as evidenced by their action when Winston promoted its cigarettes by advertising the absence of any additives. The anti-smoking groups forced R.J. Reynolds to put a special warning message on Winston ads, stating: "No additives does not mean a safer cigarette."

This is why the anti-smoking groups are full of crap. On one side of their mouths, they are arguing that finding out the ingredients in cigarettes is a great thing and will save countless lives by allowing us to somehow make cigarettes safer or less addictive. On the other side of their mouths, they attack R.J. Reynolds for taking precisely such an action - with its Winston brand - and for having the gall to suggest to its consumers that the removal of additives was a positive step for public health protection.

If the anti-smoking groups are not willing to assert that Winston cigarettes are in any measure safer or less addictive than other brands of cigarettes, then clearly the entire FDA regulation of cigarette ingredients is a complete and utter sham. Furthermore, the anti-smoking groups have been lying and massively deceiving the public by arguing that the revelation of the ingredients is a huge step forward for public health protection.

This is worth repeating. If the health groups are correct, and understanding the ingredients in cigarettes is going to lead to some measure of public health protection, then must it not be the case that Winston cigarettes have added some measure of public health protection by completely eliminating all ingredients other than the tobacco (and some water)?

Unless the anti-smoking groups are willing to concede that Winston cigarettes are safer or less addictive than other brands, then they are completely full of crap.

And since the anti-smoking groups would not in their right mind assert that Winston cigarettes are safer or less addictive then other brands, they are completely full of crap.

The rest of the story is that the disclosure and regulation of cigarette ingredients/additives is a complete scam, designed to make it look like the health groups and politicians have done something to protect the public's health, when in fact, even those very same health groups and politicians readily acknowledge that even the complete removal of every one of these ingredients and additives does not confer the slightest degree of improved safety or lowered addictiveness to cigarettes. Not a single one of these groups or politicians would argue that Winston cigarettes have a public health benefit compared to other cigarette brands.

Friday, January 22, 2010

As promised in the challenge I issued on January 12, I am today sending a $100 donation to Missouri GASP in recognition of its dissemination of the results of a study which demonstrated no effect of the smoking ban in Tuscany, Italy on heart attacks within the first year of the ban. Missouri GASP reports the results of that negative study here. Previously, GASP Missouri had posted information on studies concluding that there was a large immediate impact of smoking bans on heart attacks. Thus, Missouri GASP has answered the challenge and earned the $100 award.

In my note to Martin Pion, the president of Missouri GASP, I stated the following: "I commend you for being willing to consider the scientific evidence, even if it is “unfavorable” to our agenda. I will highlight your action on my blog and will also make a $100 donation to Missouri GASP. I hope this will set an example for other groups and demonstrate that we can promote anti-smoking policies and retain our scientific integrity at the same time. They are not contradictory to each other. Thanks for taking a leadership role in the movement in terms of scientific integrity."

The Rest of the Story

Unfortunately, Missouri GASP - under the leadership of Martin Pion - represents a very rare and unique exception to the general rule among tobacco control groups, which is: publicize only findings favorable to our position and hide studies that do not support our position. Actually, I have known Martin for some time and always found him to be an individual of the highest character and integrity. He treats opponents of smoking bans with respect, does not automatically accuse them of being funded by Big Tobacco, and is willing to consider and share all scientific data, whether favorable or not. Even in his article on outdoor smoking bans, Martin shared the quote from Gary Nolan (regional director of Citizens Freedom Alliance, which opposes smoking bans) opining that outdoor smoking bans are going too far. So I think Martin has always been an exception to the general rule I've observed in the tobacco control movement.

Other notable exceptions to this rule include the American Council on Science and Health, which is one decidedly anti-smoking group which has taken a balanced and reasonable position on tobacco issues and has been guided by science and not ideology, and Smokefree Pennsylvania, which - under Bill Godshall's leadership - has always been willing to consider the scientific data and which has in fact helped me to inform anti-smoking groups of their inaccurate claims (like me, without much success).

Why aren't there more anti-smoking groups out there like Missouri GASP, ACSH, and Smokefree Pennsylvania? I believe the answer largely has to do with the response that individuals and groups which go against the established dogma and tactics of the movement receive from the rest of the movement. You are essentially viewed as a traitor, accused of being a Big Tobacco front, accused of taking tobacco money, and generally scorned, attacked, and even censored. With that response, one wouldn't expect a lot of anti-smoking groups or individual advocates to break out of the group think mentality of the movement and to be guided by science rather than pure ideology. Even when individuals may personally have views that differ from the organization as a whole, they are hesitant to speak out because it could cost them their job. Very understandable.

The only way to create a movement in which scientific integrity returns is to restore an environment in which groups and advocates can freely share their opinions, as well as the scientific facts, without being subject to personal criticism from others. Right now, that simply does not exist in tobacco control. Believe me, it is a poisonous atmosphere in which any expression of sentiments or even facts that go against the dogma of the movement is heresy, and treated as such.

But it is comforting to know that there are at least a few shining exceptions.

Thursday, January 21, 2010

According to an Associated Press story, the first action that the Food and Drug Administration (FDA) will take to protect our nation from the hazards of tobacco use - under its new authority granted by the Family Smoking Prevention and Tobacco Control Act - is to study the ingredients of cigarettes to determine if they pose any hazard to health.

According to the story: "In June, tobacco companies must tell the FDA their formulas for the first time, just as drugmakers have for decades. Manufacturers also will have to turn over any studies they've done on the effects of the ingredients. It's an early step for an agency just starting to flex muscles granted by a new law that took effect last June that gives it broad power to regulate tobacco far beyond the warnings now on packs, short of banning it outright. Companies have long acknowledged using cocoa, coffee, menthol and other additives to make tobacco taste better. The new information will help the FDA determine which ingredients might also make tobacco more harmful or addictive. It will also use the data to develop standards for tobacco products and could ban some ingredients or combinations."

"'Tobacco products today are really the only human-consumed product that we don't know what's in them,' Lawrence R. Deyton, the director of the Food and Drug Administration's new Center for Tobacco Products and a physician, told The Associated Press in a recent interview."

"While the FDA must keep much of the data confidential under trade-secret laws, it will publish a list of harmful and potentially harmful ingredients by June 2011. Under the law, it must be listed by quantity in each brand. Some tobacco companies have voluntarily listed product ingredients online in recent years but never with the specificity they must give the FDA, said Matt Myers, president of the Campaign for Tobacco-Free Kids. For example, Altria Group Inc., based in Richmond and the parent company of the nation's largest tobacco maker, Philip Morris USA, has posted general ingredients on its Web site since at least 1999. Cigarette makers say their products include contain tobacco, water, sugar and flavorings, along with chemicals like diammonium phosphate, a chemical used to improve burn rate and taste, and ammonium hydroxide, used to improve the taste. Scientific studies suggest those chemicals also could make the body more easily absorb nicotine, the active and addictive component of tobacco. 'Until now, the tobacco companies were free to manipulate their product in ways to maximize sales, no matter the impact on the number of people who died or became addicted,' Myers said. 'The manner of disclosure previously made it impossible for the government to make any meaningful assessments.'"

The Rest of the Story

This is a complete waste of time and resources. Is this the appropriate approach to dealing with a product that we already know is killing thousands of Americans each year? Study the additives to make sure the companies aren't adding anything "harmful" to the tobacco? God forbid if cigarettes don't deliver pure tobacco.

There is also nothing new here. We already have a complete list of the cigarette additives and a list of the more than 4,000 known chemicals in tobacco smoke. Has that helped us to develop a safer cigarette? Frankly, this is complete stupidity. Actually, it's not stupidity. It's a political stunt, designed to make people feel like health groups and politicians are doing something, when they're really not.

Jeff Stier and Dr. Gil Ross of the American Council on Science and Health (ACSH) have already pointed out how inane and counterproductive this action is: "'The FDA is missing the main point,' says Stier. 'There's one really dangerous ingredient in cigarettes, and it's called 'burning tobacco.' They're worried about additives as if they'll find some other ingredient they can ban and suddenly people will be able to smoke safely.'"

"'This is a smokescreen,' says Dr. Ross. 'It's exactly what we predicted would happen when they passed this misguided law. Listing or even eliminating various ingredients is counterproductive, since it gives people the illusion that cigarettes are safer when they are not.'"

The end result of this senseless bureaucratic waste will be, at best, the following:

"According to a statement released earlier today, the Food and Drug Administration has determined that the tobacco in the cigarettes many Americans are smoking is not pure. To protect the health of American citizens, the FDA is banning these harmful additives from cigarettes. From now on, the cigarettes that smokers enjoy will contain pure tobacco, free of any undue health concerns. The cigarettes the Agency approves will now adhere to the safest, most stringent health standards in history."

"The FDA director stated: 'While we don't care if hundreds of thousands of people die from cigarettes, we don't want any of those deaths to be due to the use of unpure tobacco, adulterated with harmful additives.' The head of the Campaign for Tobacco-Free Kids added: 'This is going to save countless lives. We have finally ended the ability of Big Tobacco to poison our children by secretly, and in a sinister manner, adding harmful ingredients to the otherwise pure tobacco in their cigarettes.'"

"In response to the FDA's action, Philip Morris stated: 'As a responsible company that is committed to protecting the health of our customers, we are pleased to comply with the FDA's ban on harmful cigarette additives. Our cigarette brands will continue to meet the needs of market demand for our products, but without any hazards posed by toxic chemical additives. We look forward to complying with these strict new safety standards promulgated by the Food and Drug Administration.'"

"Federal regulators have long known the chemical ingredients in cigarettes as well as the names of 4,000 of the chemicals produced by the combustion of tobacco. Asked whether the removal of a few of these ingredients from cigarettes will result in a safer cigarette, an FDA source who spoke on condition of anonymity responded: "Well, in our opinion, even if you remove all the ingredients from cigarettes except the nicotine by producing an electronic cigarette, you don't have a safer product. Actually, what you have is a product that we are trying to get taken off the market. So what kind of stupid question are you asking? If taking all the ingredients out doesn't produce a safer cigarette, then how will taking just a few of the ingredients out help the matter?"

Anti-smoking pundit Michael Siegel issued a statement in which he said: "What a senseless waste of resources. We have put a lot of time and money into studying the ingredients of cigarettes and what have we learned? Nothing new. There are hazardous chemicals in cigarettes. Duh. We kind of already knew that... . Instead of worrying about the ingredients of cigarettes, the FDA should be using its resources to try to get people not to smoke. Prevent kids from smoking. Encourage smokers to quit. There's no need to put these kind of federal resources into studying the health hazards of smoking. We already know that this stuff is harmful for people. Now we need to do something to try to reduce smoking rates."

Siegel added: "I can see why people are increasingly frustrated with the federal bureaucracy and its inaction on major health issues. We don't have true health care reform because politicians went to bed with the insurance and pharmaceutical companies. And we don't have true tobacco control reform and a meaningful federal approach to the leading cause of preventable disease because our politicians and leading health groups went to bed with Philip Morris. If we can just get our politicians to be sleeping with each other rather than with industry, then they can be doing to each other what they're currently doing to us [1]."

Tuesday, January 19, 2010

A pair of state senators from New Jersey have publicly asserted that electronic cigarettes are more dangerous than traditional ones, and have claimed that e-cigarettes are a ploy by Big Tobacco to deceive people into thinking that their new product is safer than cigarettes.

According to a press release issued by the offices of state senators Bob Gordon and Joseph Vitale: "A bill sponsored by Sen. Bob Gordon and Sen. Joseph Vitale was signed into law this week banning the use of electronic smoking devices, commonly known as “e-cigarettes,” in indoor public places and the sale of the devices to minors. “This is yet another victory for public health,” said Sen. Gordon (D-Bergen). “No matter how manufacturers attempt to market these devices, they are still cigarettes. In many ways, they may be more dangerous than traditional cigarettes because of their lack of oversight or any conclusive studies into their health effects.”

“With all of the overwhelming statistics on the hazards of smoking, the e-cigarette is nothing more than an attempt by the tobacco industry to reinvent itself as a healthier alternative,” said Sen. Vitale (D-Middlesex). “Meanwhile, they are using propylene glycol, a known irritant, to create the vaporizing effect of the cigarette.” ...

“The legend of Joe Camel rears its ugly head. Tobacco product manufacturers know they have a much better chance of hooking people on their products if they can get to them when they’re younger, less informed and feel invincible. This law sends a clear message that we’re not going to stand for that,” added Sen. Vitale, who also sponsored the Smoke Free Air Act and a 2008 law banning the sale of flavored traditional cigarettes in New Jersey."

The Rest of the Story

It appears that Senator Gordon needs a remedial basic science course. There is no way that a product which delivers nicotine from a vaporized propylene glycol solution with only traces of carcinogens is more dangerous than cigarettes - which deliver nicotine plus thousands of other chemicals, including more than 40 carcinogens. By asserting that these products may be more dangerous than cigarettes, Gordon is actually telling the public that there is reason to believe that cigarette smoking is safer than vaping. Such an assertion is not only scientific hogwash, but it is irresponsible and amounts to what I would consider as public malpractice. It is going to cause major harm to people because if vapers believe Gordon and return to smoking for fear of health effects from electronic cigarettes, they are going to suffer substantial health harm.

Senator Vitale may not need a remedial science course, but he may need a lesson in not telling lies to the public. It is a material misrepresentation of the truth to assert that electronic cigarettes are produced or marketed by the tobacco industry. Big Tobacco has nothing to do with the electronic cigarette. These products are not manufactured by nor marketed by tobacco companies.

I believe it is irresponsible for public policy makers to be so misinformed about issues of this magnitude and importance. They have every right to take a different position on the issue of the use of electronic cigarettes in public, but to justify their decision based on untruths is inappropriate and it represents a major disservice to the public they are supposed to be serving.

I believe public policy makers ought to do a little more careful research before taking positions and making public pronouncements like Senators Gordon and Vitale have done. At least, get your facts straight before you end up disseminating lies to the public.

Fortunately, the judicial branch of government may be serving as a balance to the apparent ignorance of many in the legislative branch. The DC district court has ruled that the FDA may not ban electronic cigarettes and if the ruling holds, I believe states will not be able to ban electronic cigarettes either. This is because the Family Smoking Prevention and Tobacco Control Act preempts states from enacting their own tobacco product standards. Those standards include provisions for the banning of certain types of tobacco products, according to the Act. Thus, there is a strong argument that federal law now preempts states from banning electronic cigarettes. That will keep misinformed state legislators like Gordon and Vitale from taking potentially life-saving electronic cigarettes off the market.

The tobacco industry must really be enjoying this. Their products are being described as safer than relatively clean solutions of nicotine and propylene glycol. With "enemies" like Gordon and Vitale, it's hard to imagine the tobacco industry's need for legislative friends.

Monday, January 18, 2010

On Thursday, I reported the U.S. District Court ruling in which a preliminary injunction was issued against the FDA taking any action to regulate electronic cigarettes as drugs/devices under the federal Food, Drug, and Cosmetics Act. Today, I discuss the implications of this ruling, assuming that it is upheld after further judicial review.

I believe that the court ruling, if upheld, will have the following major implications for electronic cigarettes:

1. Electronic Cigarettes Would Be Approved for Sale and Marketing in the United States

The major implication of the court's ruling is that electronic cigarettes will be defined as tobacco products, meaning that they will not be regulated as drugs/devices under the Food, Drug, and Cosmetic Act. Instead, they will be regulated as tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009.

The most important implication is that instead of being unapproved drugs subject to enforcement action which could have included taking the product off the market completely, electronic cigarettes would instead be in the category of tobacco products, and by virtue of their existence prior to the passage of the tobacco control act, they would be officially approved for sale and marketing in the United States.

Moreover, because the tobacco act precludes the FDA from banning any particular type of tobacco product, the FDA would not have the authority to remove electronic cigarettes from the market, even if the Agency wanted to take such action.

This would be a tremendous victory for public health because this potentially life-saving product which is clearly helping thousands of ex-smokers to stay off cigarettes would remain available. It would prevent these thousands of ex-smokers from returning to smoking, which would inevitably occur if electronic cigarettes were taken off the market.

Many public health groups, such as the Campaign for Tobacco-Free Kids, see it the opposite way. For example, the Campaign argued that the court's ruling dealt a "blow to public health." The Campaign's reasoning: "If upheld, Judge Leon’s decision opens a gaping loophole in the protection FDA has provided against the sale and distribution of non-tobacco products that a manufacturer laces with unregulated quantities of nicotine."

In other words, according to the Campaign, it is far better for smokers to consume traditional cigarettes that deliver thousands of chemicals and scores of carcinogens than it is to quit smoking and switch to a product that delivers nicotine without those chemicals and carcinogens, because we're not sure exactly what amount of nicotine is being delivered.

What a load of garbage!

Who cares whether there are differences in the amount of nicotine that the product delivers? Any variation in nicotine delivery will result in decreased addiction potential, not increased potential, as the Campaign asserts. Why do you think that the tobacco companies carefully regulate the amount of nicotine in their products? Simple. Because if the product delivers exactly the same amount of nicotine, it enhances the addiction potential.

Why is it better for smokers to continue smoking and suffer diseases and death from the chemicals and carcinogens in tobacco than to quit smoking altogether and instead use a nicotine-delivery product, even if the amount of nicotine delivered varies from cartridge to cartridge?

Jacob Sullum put it best when he questioned the scientific competence of the groups putting forward these senseless arguments: "In fact, as I've noted before, there is no question that puffing on a smoke-free e-cigarette is much less hazardous than lighting tobacco (or anything else) on fire and sucking the combustion products into your lungs. This is a point so obvious that only the FDA and a certain brand of zero-tolerance anti-tobacco activist would try to deny it."

Groups like the Campaign for Tobacco-Free Kids are zero-tolerance activist groups because they cannot tolerate the idea of someone going through the act of what looks like smoking a cigarette, even if it is orders of magnitudes safer for them. Better that they should die smoking a product with absolutely well-known hazards than use a product which looks like smoking and from a scientific basis, must be safer, but which looks like the person is still smoking. Either these groups are ignoring science for ideology, or their scientific judgment is severely impaired.

In summary, the first implication of the court's ruling (if upheld) is that it will save the American public from the scientific incompetence and/or blinding ideology of the anti-smoking groups. Electronic cigarettes will remain a legal and viable for smokers who are concerned about the effects that cigarettes are having on their health.

2. Electronic Cigarettes Could Not Market Their Products as a Smoking Cessation Device

A key provision of the court's ruling was that electronic cigarettes are not drugs or devices because they are not intended to affect the structure or function of the body or to treat any disease or condition. However, if electronic cigarettes were to be marketed primarily as a tool for smoking cessation, then they would suddenly meet the definition for a drug or device, and would be subject to regulation under the Food, Drug, and Cosmetic Act.

The implication of this aspect of the ruling is that electronic cigarettes may not be marketed primarily as a smoking cessation tool, even if there arises evidence that these products are effective for such a purpose.

This has unfortunate consequences for the public's health, because it will make it more difficult to convince smokers who are otherwise unable to quit to try quitting smoking using electronic cigarettes. Electronic cigarette distributors will simply have to live with this aspect of the ruling. They will have to discontinue and/or refrain from making any claims that their products are effective devices for smoking cessation.

3. Electronic Cigarettes Could Not Claim to Be Safer Than Traditional Cigarettes, or to Be Safer Alternatives to Smoking

Even though it is almost certainly true that electronic cigarettes are safer than traditional ones (i.e., vaping is much safer than smoking), electronic cigarette manufacturers would not be able to make such a claim because doing so would classify the product as a "modified risk tobacco product." Doing so would require an almost impossible task: demonstrate with solid scientific evidence that these products reduce disease among individuals and among the population as a whole. This would require long-term epidemiologic studies and/or clinical trials and it is unlikely that such a massive undertaking could be financed by these relatively small companies. It would also take long-term studies - looking out 20 years or so - to demonstrate that disease rates are lower. It simply will not happen. Thus, the effective implication of the ruling is that electronic cigarettes cannot be marketed as a safer alternative to smoking.

This implication is also unfortunate, but it is a direct result of the tobacco act's unscientific approach to harm reduction strategies.

4. Electronic Cigarettes Could Claim to Reduce Delivery of Certain Constituents, But Would Have to Undertake Studies and Receive FDA Approval, Which is Unlikely

A major implication of the court's ruling is that in order to market electronic cigarettes as devices which reduce the delivery of certain tobacco constituents (chemicals and carcinogens), electronic cigarette distributors would have to obtain FDA approval. This is because if they made such claims, electronic cigarettes would be classified as "modified risk tobacco products" making "reduced exposure" claims. They would have to first show that it is anticipated that these products would reduce disease. That would be quite easy. However, the companies would also have to produce market research data showing that the provision of this information to consumers will not result in the perception that electronic cigarettes are safer than traditional cigarettes. This would be a much more difficult undertaking and would likely require companies to "fix" the results by asking inappropriately worded questions. It is therefore possible, but unlikely, that this approval could be obtained.

Thus, combining implications #1 through #4, the net effect of the court's ruling is that electronic cigarettes would be approved and permanently allowed on the market, but they would most likely not be able to make any claims regarding effectiveness in smoking cessation, relative safety compared to traditional cigarettes, or even reduced exposure to cigarette smoke constituents.

Of course, public health agencies and organizations could make such claims. Essentially, electronic cigarettes would have to be marketed purely as alternative smoking devices, and the promotion of the product as a safer alternative to smoking would have to be done by outside sources, such as public health agencies and groups, physicians, etc.

5. Electronic Cigarettes Could Not Be Sold Legally to Minors and Would Be Subject to Sales and Advertising Restrictions to Prevent Their Sale to Minors

As tobacco products, electronic cigarettes would most likely be subject to the sales and advertising restrictions put upon tobacco products by the Family Smoking Prevention and Tobacco Control Act. They could not be sold to minors, would not be able to advertise in media with high youth exposure, and would be subject to sales restrictions, such as age identification checks and other measures.

This implication is a good one, because it helps ensure that electronic cigarettes will not find their way into the hands of minors. This is a significant concern of many public health groups. The classification of electronic cigarettes as tobacco products would substantially ease this concern, as these products would be regulated in a similar manner as other tobacco products in terms of their sale to minors.

6. States Would Most Likely Not Be Able to Ban Electronic Cigarettes

As tobacco products under the Family Smoking Prevention and Tobacco Control Act, electronic cigarettes would be subject to the preemption clause in the legislation which prohibits state and local governments from issuing tobacco product standards that are different from those under the provisions of the federal law. Thus, it may be that states are not authorized to promulgate their own bans on electronic cigarettes.

According to section 916(a)(2)(A): "No State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this chapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products."

The key question, then, is whether a ban on a particular type of tobacco product is considered as relating to "tobacco product standards." Tellingly, the Act's provision in which the FDA is precluded from banning any particular type of tobacco product is part of the "Tobacco Product Standards" section of the legislation (section 207). Thus, it is most likely the case that a ban on electronic cigarettes would be considered a tobacco product standard.

This most likely means that states may not ban electronic cigarettes, because such an action is in violation of the preemption clause in section 916(a)(2)(A). This may be the single most important implication of the court's decision. I have not yet seen any commentary in which this implication has been mentioned. But it is an important one because in the absence of a federal ban on electronic cigarettes, many states will likely pursue bans of their own. The court's decision appears to me to protect electronic cigarettes from state bans. This would not apply, however, to brands of electronic cigarettes that are advertised as smoking cessation products (because such products would not be defined as tobacco products and thus would not be protected by the preemption provision of the tobacco act).

The United States District Court for the District of Columbia today ruled that most likely, the Food and Drug Administration (FDA) does not have the authority to regulate electronic cigarettes as drug-device combinations under the U.S. Food, Drug, and Cosmetic Act, and may instead regulate these products as "recreational" tobacco products under the Family Smoking Prevention and Tobacco Control Act.

The Court issued a preliminary injunction against the FDA, which prohibits the FDA from taking any action against electronic cigarettes on the basis of its assertion that these are unapproved drug delivery devices that must comply with the Food, Drug, and Cosmetic Act. That injunction will hold until such time as the Court fully reviews the case and issues a final decision.

The decision to grant the preliminary injunction indicates that the Court finds that there is a substantial likelihood that the case will succeed and that the FDA will be found not to have authority to regulate electronic cigarettes as drug-delivery devices.

The lawsuit was brought by two electronic cigarette distributors - Smoking Everywhere and NJOY - whose companies had shipments of their products detained by the FDA on the ground that these electronic cigarettes are unapproved drug delivery devices.

The basis for the Court's decision is that the term "tobacco product" is defined very broadly in the Family Smoking Prevention and Tobacco Control Act (which I will subsequently refer to as "the Act"). In the Act, tobacco products are defined as: "any product made or derived from tobacco that is intended for human consumption." Since the nicotine in electronic cigarettes is extracted from tobacco and intended for consumption, the Court finds, at first blush, that electronic cigarettes are a "tobacco product" under the Act.

The Act does provide an exception for any article that is a drug, device, or drug-device combination under the Food, Drug, and Cosmetic Act. The FDA argued that because electronic cigarettes are intended to effect the structure and function of the body in the way that cigarettes do, they are drug delivery devices and therefore not tobacco products.

However, the Court found a serious flaw in this logic. By that reasoning, tobacco products themselves would be exempt from the Act because they themselves are intended to effect the structure and function of the body. As the Court noted, any tobacco product that claimed to have some pharmacologic effect on the body would be excluded from the definition of "tobacco product" under the Act using the FDA's reasoning.

In other words, it is clear that Congress' intent was not to exclude products derived from tobacco that deliver nicotine from definition as tobacco products merely because they deliver nicotine and thus are intended to affect the structure and function of the body.

The FDA argued that the marketing of electronic cigarettes for the purpose of achieving relief of nicotine withdrawal symptoms represented health claims of a therapeutic effect that put electronic cigarettes in the category of drug-device combinations. The Court found that the overall nature of electronic cigarette marketing by Smoking Everywhere and NJOY was essentially framing these products as alternatives to cigarettes, rather than specifically as a nicotine cessation device. Thus, the Court ruled, electronic cigarettes are not intended to prevent or treat nicotine addiction.

Finally, the Court also found that advertising e-cigarettes as a healthier alternative to smoking does not put them in the category of a drug-device combination. Instead, this would put them into the category of a modified risk tobacco product under the Act.

The Court concludes: "In sum, absent substantial evidence of the manufacturer's objective intent that its electronic cigarettes affect the structure or function of the body in a way distinguishable from "customarily marketed" tobacco products or that its electronic cigarettes have the therapeutic purpose of treating nicotine withdrawal, there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette. Thus, the plaintiffs are substantially likely to succeed on their claim that FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA."

The Court also considered the FDA's argument that removal of electronic cigarettes from the market is a huge public health benefit that outweighs any economic harm to the e-cigarette companies. However, the Court found that the FDA's argument was greatly exaggerated and failed to find any reason to think that removing electronic cigarettes from the market would protect the public's health. In fact, the ruling specifically states that there is no reason to believe that electronic cigarettes are any more dangerous than traditional cigarettes:

"While FDA's interest in protecting public health and safety is, in the abstract, paramount to plaintiffs' purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public."

The Court's decision actually concludes by chiding the FDA for trying, once again, to regulate tobacco products as drugs or devices under the Food, Drug, and Cosmetic Act: "This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable."

The Rest of the Story

The immediate effect of this decision is to prevent the FDA from taking any further action against electronic cigarette distributors on the basis that these products are unapproved drugs or devices under the federal Food, Drug, and Cosmetic Act. The injunction is preliminary, meaning that the Court will thoroughly review the case and then issue a final ruling. Thus, this does not represent a final decision. It merely reflects that the Court sees a substantial likelihood of success on the merits of the case.

If this decision is ultimately upheld, then electronic cigarettes will be classified as tobacco products under the Family Smoking Prevention and Tobacco Control Act and will be regulated like all other tobacco products, which means they will be officially approved and given the government's blessing (which would be a good thing, since the deadly tobacco products which kill hundreds of thousands of people every year are given the government's blessing under that Act).

However, it should be noted that electronic cigarette distributors who make claims that electronic cigarettes are safer than traditional cigarettes would be rendering their products into the category of modified risk products, and would have to meet very stringent criteria in order to continue to market their products in that way. The net effect would be to prevent companies from making such claims in the first place if they wish to sell electronic cigarettes.

Tuesday, January 12, 2010

A peer-reviewed study published in the European Journal of Epidemiology has concluded that there was no significant effect of the smoking ban in Tuscany, Italy on heart attacks during the first year of implementation (see: Gasparrini A, Gorini G, Barchielli A. On the relationship between smoking bans and incidence of acute myocardial infarction. European Journal of Epidemiology 2009; 24:597-602).

This is the first published study to report no significant effect of a smoking ban on heart attacks.

The smoking ban in Italy went into effect on January 10, 2005. The investigators compared incident cases of acute myocardial infarction (heart attacks) among the Tuscany population (which is about 3.6 million) during the five-year period before the ban (2000-2004) with the number of cases during the first year after the ban (2005).

Monthly, age-standardized rates for acute myocardial infarction were determined for the entire study period and a Poisson regression model was used to assess the significance of any changes in heart attack incidence during 2005 compared to the baseline period. The analysis controlled for seasonality, long-term trends, and changes in the age distribution of the population.

Two models were tested: a linear model and a non-linear model. In the linear model, the authors found that the smoking ban was associated with a non-significant 5.4% reduction in the heart attack rate in 2005. In the non-linear model, the authors found that the smoking ban was associated with no effect whatsoever on heart attack rates (a non-significant 1% increase).

The article concludes: "Differently from the results published to date, this study did not find a comparable effect of the smoke-free law on the incidence of AMI [acute myocardial infarction] during the first year after the implementation of the ban. Our estimate and the related uncertainty suggest that the expected reduction is likely to be lower. ... The estimate of the effect of the ban seems to be highly sensitive to the model specification and to the effects of unaccounted factors which could modify the trend of AMI incidence, such as changes in the prevalence of other risk factors or the modification of diagnostic criteria. Several arguments which are put forward to inspect the causal relation between smoking bans and AMI indicate that the plausible effects could be lower than the estimates reported so far."

The authors close by stating: "The implementation of smoking bans in public places represents a milestone in the history of public health. The relationship with a decrease of both active and passive smoke is unquestionable, with conclusive evidences on the reductions of a number of health outcomes after the enforcement. In particular, a decrease of cardiovascular events in the long run is expected, given the conclusive association with chronic SHS exposure. On the other hand, the estimate of the short-term effect of smoking bans on cardiovascular diseases is still uncertain, and the range of reduction showed by some of the studies published to date is likely to be an overestimate, not consistent with previous knowledge about the burden of cardiovascular diseases attributable to SHS. Moreover, several other factors, like changes in diagnostic criteria, have a strong influence on the trend of cardiovascular diseases, and it seems very problematic to properly control for their effects with this study design. Nonetheless, as this study has shown, the resulting bias could be substantial."

The Rest of the Story

This study has a number of important strengths compared to the previous literature on this research question. First, it covers a large population of about 5.6 million people. The results are based on a total of 13,456 new cases of myocardial infarction. This compares with only 304 heart attacks in the Helena study.

A second advantage of this study is that the identification of heart attack cases is based on a registry (the Acute Myocardial Infarction Registry of Tuscany), which provides consistent surveillance for heart attacks occurring throughout the study period. This differs from studies such as the one in Scotland, where different methods were used to identify heart attacks occurring pre-ban and post-ban.

Perhaps the most important strength of the study is that it included a reasonable baseline period of five years, rather than just one or two years prior to the implementation of the smoking ban, which was the case in many of the previous studies.

A final strength of this study is that it considered both linear and non-linear trends in heart attacks to model the results. But it is important to note that even with a linear trend assumption, the study found no significant effect of the smoking ban and the estimated magnitude of the association was quite small (just 5.4%).

Importantly, this published study was not considered by the Institute of Medicine committee which reviewed this issue and released its report in October of last year. It was also not considered in published meta-analyses on this topic. Because of the high sample size of this study, it is likely that inclusion of this study in the previous meta-analyses would have negated their results.

While one study does not prove or disprove a hypothesis (one always needs to look at the totality of the evidence), this study is important because it is not consistent with the conclusions that have been widely disseminated by anti-smoking groups. The interesting thing to observe will be whether or not these findings are even reported by these groups.

Based on my experience in the anti-smoking movement, I am willing to bet that not a single group which previously reported the results of studies "favorable" to their cause will now report the results of this negative study. In fact, I'm so sure that no group will do this that I am putting up a $100 reward for the first group that does. I will contribute $100 to the first anti-smoking organization that previously reported the results of one of the positive studies and which now reports the results of this negative study.

I'm not worried about losing my money because as I've recently learned, it's not the quality of the science or the truth that is important. It's the favorability of the findings. Anti-smoking groups have largely lost their scientific base and scientific integrity and they are now turning into propaganda machines which are only interested in disseminating findings that are favorable to their cause. They will not share unfavorable findings because the ultimate goal is not the truth and the scientific facts, but the supporting of the agenda.

I'd love to be proven wrong. It can be done simply by emailing me the link to an anti-smoking group's dissemination of the results of the Tuscany study. I'll be waiting.

Monday, January 11, 2010

According to the headline of a Swiss news site -- "Smoking Ban Linked to Drop in Heart Attacks" -- a new study shows that a regional smoking ban in Switzerland led to a 22% decline in heart attacks in the Graubuenden canton where it was adopted. The study was published online in the journal Swiss Medical Weekly (see: Trachsel LD, Kuhn MU, Reinharf WH, Schulzki T, Bonetti PO. Reduced incidence of acute myocardial infarction in the first year after implementation of a public smoking ban in Graubuenden, Switzerland. Swiss Medical Weekly, January 7, 2010).

According to the news article, one of the study authors "says that while causality cannot be proven, there is a strong case for a link between the ban and the number of heart attacks, especially given the lack of other obvious culprits. 'The strongest argument for causality is that more than ten studies worldwide have come up with similar results,' he said. 'If you take all these studies together, you get an average decrease of 17 per cent in the first year after a ban is implemented.'"

The public smoking ban in Graubuenden, which prohibits smoking in all public buildings, cafes, bars, and restaurants, went into effect on March 1, 2008. The study examined the number of heart attack admissions at a large, tertiary care hospital in Graubuenden, which reported is the only hospital in the canton to perform cardiac catheterization and therefore, virtually all patients who suffer a heart attack are reportedly seen at this hospital.

The number of heart attack admissions was recorded for the first year following the smoking ban (March 2008 through February 2009) and compared to the same period during the previous two years (March 2007 through February 2008 and March 2006 through February 2007).

The number of heart attack admissions during these three periods was as follows:

2006-2007: 229

2007-2008: 242

2008-2009: 183

Thus, there was a 20% reduction in heart attacks from 2006/07-2008/09 and a 24% reduction from 2007/08-2008/09, or an average reduction of 22%.

The Rest of the Story

The primary reason why this is shoddy science is that the study lacks something very important: a comparison group.

Simply knowing that the number of heart attacks in Graubuenden declined by 22% in the first year after implementation of the smoking ban went into effect doesn't prove that the smoking ban was the reason for the observed reduction in heart attacks. It could well be that heart attacks for all of Switzerland also declined substantially during the same time period.

The only way to evaluate whether or not the observed decline of 22% was attributable to the smoking ban, rather than just indicative of a general secular trend of declining acute coronary events, would be to compare the trend in heart attacks in Graubuenden with the trend in some comparison area, such as other cantons in Switzerland, which did not have a smoking ban.

In the absence of any such comparison group, it is not appropriate (and not scientifically legitimate) to conclude that the observed decline in heart attacks is attributable to the smoking ban. There are many other factors that could have caused the decline, not the least of which is that heart attack admissions decreased substantially during the same time period in many regions throughout the world, due in part to advances in medical treatment of heart disease, hypertension, and hypercholesterolemia, and to declines in smoking that are occurring even in the absence of smoking bans.

The Study Itself Shows that Its Conclusion is Invalid

What makes this study much more problematic -- going well beyond merely being shoddy science -- is that the article draws a conclusion which is refuted by the very data presented therein.

To understand the rest of this story, you need to first appreciate the nature of the Graubuenden canton. As described in the research article: "because of its unique landscape Graubuenden is the largest holiday destination of the country, offering a multitude of recreational activities in all seasons. Hence, a total of ≈6million visitor overnight stays are recorded in Graubuenden every year. Based on the large number of visitors, the population of the Canton of Graubuenden may almost double during the holiday season."

Now here is the critical point: if the smoking ban were the cause of the decline in heart attacks, then the decrease in heart attacks should be observed only among residents of the canton of Graubuenden. One would not expect to see a substantial decline in heart attacks among non-residents, who just happen to be vacationing there for perhaps a week or even less. In a sense, the non-resident visitors to Graubuenden represent a sort of internal comparison group.

The study did examine the differences in the trend in heart attacks among Graubuenden residents compared to non-residents during the relevant time periods. Here are the results, showing the average observed decline in heart attacks in the first year following the smoking ban for residents versus non-residents:

Residents: 22.8%

Non-Residents: 20.6%

As the reader can easily see, there was absolutely no significant difference between the decline in heart attacks among residents versus non-residents. This pretty much dispels any notion that the observed decline in heart attacks was attributable to the smoking ban. In fact, it provides evidence that heart attacks among residents of other cantons in Switzerland, and among the population in general, were declining during the same time period.

Although in his quote to the press, one of the study authors stated that there are no other obvious "culprits" that could explain a decline in acute coronary events, the research paper suggests otherwise. The paper notes that: "an increase in the use of lipid-lowering drugs during the study period might represent an issue. Indeed, since 2006, sales figures of lipid-lowering drugs increased gradually by about 9% every year in the Canton of Graubuenden."

In my opinion, not only is this new study of the Helena et al. ilk invalid in its conclusions and not only is the study shoddy because of its failure to include a comparison group, but the article seems to be heavily biased and to ignore the very data reported in the paper itself. The interpretation of the study's findings appears to be quite biased towards trying to show that there was a significant effect of the smoking ban.

While I understand the source of this bias (I, too, would love to see an immediate and dramatic effect of smoking bans on heart attacks, especially since I have devoted so much of my career to promoting such policies), it is unfortunately clouding the scientific process.

The bottom line is that this study does not support the conclusion that the smoking ban led to a 22% reduction in heart attacks and in fact, it provides some evidence that any observed reduction in heart attacks was due to a secular trend of declining heart attacks that was observed in residents and non-residents alike.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.